Clinical trial · Interventional
Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiofrequency Ablation with External Beam Radiation
- description
- Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
- interventionNames
- Procedure: radiofrequency ablation
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Two Year Progression Free Survival Rate
- timeFrame
- 2 years
- description
- the number of patients surviving progression-free at two years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer
* Cytology or biopsy-proven disease
* Stage IA (T1N0M0) or select stage IB (T2N0M0 because of visceral pleural involvement or size ≥ 3.0 cm)
* Tumor size ≤ 3.5 cm
* No bronchioloalveolar carcinoma
* Node-negative patients will have hilar or mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on fludeoxyglucose F 18 (FDG)-PET in those areas
* Patients with \> 1.5 cm lymph nodes and clinically suspicious FDG-PET uptake will still be eligible if directed tissue biopsy or needle aspiration of abnormally identified area are negative for cancer
* Patients with \> 1.5 cm and \< 2.0 cm lymph nodes and no clinically suspicious FDG-PET uptake in those areas will still be eligible
* All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to comorbid conditions
* CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion must be determined to be in a location where radiofrequency ablation is technically achievable based on the proximity of adjacent organs and structures
* Any patient with suspected M1 disease based on pre-treatment PET-CT imaging should have biopsy if possible
* If the biopsy is positive, the patient should be treated as per the clinician's preference off of this protocol
* If the biopsy is negative and representative of the lesion in question then the patient may be treated as per this protocol
* If the biopsy is non-diagnostic, consideration should be given to repeat biopsy
* If the repeat biopsy remains non-diagnostic or a biopsy is not feasible than the patient will not be eligible for this protocol and should be treated per the clinician's preference
PATIENT CHARACTERISTICS:
* Inclusion Criteria:
* ECOG performance status 0-2
* Women of childbearing potential must have a negative pregnancy test
* Fertile women must use effective contraception
* Exclusion Criteria:
* History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA level \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to study entry
* Pregnant or lactating women
PRIOR CONCURRENT THERAPY:
* Exclusion Criteria:
* Previous chest radiation to the lung or mediastinum
* Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
* Radiotherapy
* Radiofrequency ablation
* Other antineoplastic interventional radiology techniques
* Chemotherapy
* Biological therapy
* Vaccine therapy
* Surgery
* Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowedReferences
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